Which of the following is an example of 'competent human intervention' as described in the 1989 FDA policy?

• A. A nurse stopping a patient from taking the wrong drug
• B. A physician deciding not to follow the advice of a clinical decision support system
• C. A chairperson of an FDA panel helping the panel to reach consensus on approving a piece of clinical software
• D. A health IT professional assuring that an electronic medical record is configured properly

Answer: (B)

The idea being tested is that automated decision guidance is meant to support, not replace, a clinician’s professional judgment. Competent human intervention means a clinician uses their expertise to verify and, when necessary, override computer-generated recommendations to fit the specific patient.

In the example where a physician decides not to follow the advice of a clinical decision support system, we see this judgment in action. The physician weighs the CDS input against patient-specific factors—such as history, allergies, current medications, and unique risks—and chooses a course that is safest for that individual. This demonstrates competent human intervention because the clinician maintains ultimate responsibility for the decision and uses professional reasoning to determine whether the automated guidance is appropriate.

The other scenarios illustrate important safety or governance roles but do not demonstrate the physician applying professional judgment to override automated guidance in a patient-care context—that is the essence of competent human intervention described in the policy.